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Replies to #41427 on Biotech Values
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daved

02/01/07 9:27 AM

#41435 RE: iwfal #41427

Re mph/mcu mortality from iwfal. That is extremely important information. I'll probably sell if true. Where can I read about it?

BTW, I agreed with your earlier statement that nowhere in writing is it established that the protocol calls for an MI definition including peak CK-MB > 100ng. The post P2 meeting with the FDA reported April 12, 2006 indicated that probability.

I called Hogan Mallally on your point. He cited 4 other trials in which the FDA had agreed to the definition including the above specs. He confirmed to me that the protocol did include the 100 ng/ml as part of the definition of MI.

Dave